Radiation Therapy With or Without SU5416 in Treating Patients With Soft Tissue Sarcoma (NCT00023725) | Clinical Trial Compass
CompletedPhase 1/2
Radiation Therapy With or Without SU5416 in Treating Patients With Soft Tissue Sarcoma
United States, CanadaStarted 2001-08
Plain-language summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as SU5416 may stop the growth of cancer by stopping blood flow to the tumor. It is not yet known if radiation therapy is more effective with or without SU5416 in treating soft tissue sarcoma.
PURPOSE: Phase I/II trial to compare the effectiveness of radiation therapy with or without SU5416 in treating patients who have stage IB or stage IIA soft tissue sarcoma.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
DISEASE CHARACTERISTICS:
* Histologically confirmed primary or locally recurrent stage IB or IIA soft tissue sarcoma
* Grade 1 or 2
* Tumor greater than 5 cm in diameter
* Tumor located on upper extremities (including shoulder), lower extremities (including hip), or body wall
* No sarcoma of the head and neck or intra-abdominal or retroperitoneal sarcoma
* No desmoid tumor or dermatofibrosarcoma protuberans
* No metastatic disease
* No evidence of lung metastases
* Maximum of 4 lung lesions no greater than 5 mm in diameter each on preoperative chest CT scan allowed OR
* Lesion no greater than 1 cm allowed if stable for at least 1 year and fits criteria for granuloma
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* Zubrod 0-1
Life expectancy:
* At least 2 years
Hematopoietic:
* WBC at least 4,000/mm\^3 OR
* Absolute neutrophil count at least 1,800/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic:
* Bilirubin no greater than 1.5 mg/dL
* SGOT no greater than 50 U/L
* PT and PTT less than 1.25 times normal (not on warfarin)
Renal:
* Creatinine no greater than 1.5 mg/dL OR
* Creatinine clearance greater than 50 mL/min
Cardiovascular:
* No congestive heart failure or myocardial infarction within the past 6 months
* No uncompensated coronary artery disease
* No severe peripheral vascular disease
* No peripheral vascular disease with diabetes mellitus
* No deep venous or arterial thrombosis within the past 3 months
* Fibrin split produc…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.